Cleared Special

K133242 - STELLARIS VISION ENHANCEMENT SYSTEM (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133242 · Bausch & Lomb · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
116d
Days
Class 2
Risk

K133242 is an FDA 510(k) clearance for the STELLARIS VISION ENHANCEMENT SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Bausch & Lomb (St Louis, US). The FDA issued a Cleared decision on February 14, 2014 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bausch & Lomb devices

Submission Details

510(k) Number K133242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date February 14, 2014
Days to Decision 116 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 314
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